Alkermes plc’s placebo-controlled phase II study of alixorexton in treating narcolepsy type 2 (NT2) hit its dual primary endpoints, producing statistically significant and clinically meaningful improvement in wakefulness and excessive daytime sleepiness. Alkermes said alixorexton is the first oral orexin 2 receptor agonist that has shown efficacy in a large phase II clinical trial in those with NT2. Read More
In reaching within to name 26-year FDA veteran Richard Pazdur as the next CDER director, FDA Commissioner Marty Makary likely chose the best possible person to helm the drug evaluation center at a time marked by uncertainty, morale issues and upheaval, according to several agency watchers. Read More
Recent progress in redressing the historical underfunding and neglect of women’s health could be undermined by the backlash against diversity, equity and inclusion (DEI) initiatives, according to executives participating in the FT Global Pharma and Biotech Summit 2025 in London Nov. 11-12. Read More
The U.S. House is expected to vote late Nov. 12 on an amended continuing resolution (CR) to end the historic 43-day partial government shutdown. Already passed by the Senate, the CR would fully reopen the government and fund it through Jan. 30. President Donald Trump has said he will sign the CR, which ensures federal employees furloughed during the shutdown will receive back pay and will not be terminated. Read More
At the busy annual congress of the American College of Surgeons in Chicago, attendees heard about a study that found rectal bleeding in younger adults – those under 50 years of age – increased their odds of a colorectal cancer (CRC) diagnosis by a shocking 850%. Already, the demographic has turned up sharply higher cases of the disease in recent years. The ACS meeting was held Oct. 4-7. Read More
Laekna Inc. outlicensed select rights to LAE-002 (afuresertib), an oral pan-AKT kinase inhibitor licensed from Novartis AG in 2018, to Qilu Pharmaceutical Co. Ltd. under a potential ¥2.045 billion (US$287.23 million) deal. Read More
Editor Annette Boyle discusses the challenges med-tech companies face in bringing innovation to market and how the industry can overcome them. Read More
New hires and promotions in the biopharma industry, including: Abcellera, Evox, Medincell, Odyssey, Pharmaessentia, Prokarium, Santa Ana, Trimtech. Read More
Biopharma happenings, including deals and partnerships, and other news in brief: Bayer, Eli Lilly, Insilico, Kezar, Neuphoria, Oncotelic, Sapu, Vividion. Read More
